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Orphan Device
An orphan device is a product or an equipment intended for the prevention, prediction, diagnosis, support, treatment or management of a life-threatening or chronically debilitating disease with a low prevalence/ incidence, most notably for rare diseases. Orphan medical technology is then considered as both the medical device (tool or equipment) and the connectivity of the device. Many orphan devices provide essential functions for patients with rare diseases, their carers, and the healthcare professionals using them. Nevertheless, there are very few medical devices that are specifically developed for rare diseases (in contrast to orphan medicinal products). At the same time, many patients and carers express a substantial unmet need for new medical devices for their conditions. Orphan devices constitute a very diverse group of products, reflecting the broad field of rare diseases. Device needs for rare diseases vary from noninvasive markers for monitoring disease activity, wearab ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cite Note-1
{{disambiguation, callsign ...
To cite is to quote or mention a source. CITE or Cite may refer to: * Cite (cycling team), Italy * ''Cite'' (magazine), an American architecture quarterly * CITE-FM, a Canadian radio station * Center for Innovation Testing and Evaluation, a proposed facility in New Mexico, US * Centre for IT Education, Bhubaneswar, India * Certified Incentive Travel Executive, a meeting and convention planner See also * Cité (other) * CITES, a treaty * Citation (other) A citation is a credit or reference to another document or source. Citation may also refer to: Government, law, and military * Citation (police), a type of summons compelling the appearance of a defendant before the local magistrate * Traffic ci ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Life-threatening Disease
Lethality (also called deadliness or perniciousness) is how capable something is of causing death. Most often it is used when referring to diseases, chemical weapons, biological weapons, or their toxic chemical components. The use of this term denotes the ability of these weapons to kill, but also the possibility that they may not kill. Reasons for the lethality of a weapon to be inconsistent, or expressed by percentage, can be as varied as minimized exposure to the weapon, previous exposure to the weapon minimizing susceptibility, degradation of the weapon over time and/or distance, and incorrect deployment of a multi-component weapon. This term can also refer to the after-effects of weapon use, such as nuclear fallout, which has highest lethality nearest the deployment site, and in proportion to the subject's size and nature; e.g. a child or small animal. Lethality can also refer to the after-effects of a major chemical or oil/gas process loss of containment, causing fire, ex ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Incidence (epidemiology)
In epidemiology Epidemiology is the study and analysis of the distribution (who, when, and where), patterns and Risk factor (epidemiology), determinants of health and disease conditions in a defined population, and application of this knowledge to prevent dise ..., incidence reflects the number of new cases of a given medical condition in a population within a specified period of time. Incidence proportion Incidence proportion (IP), also known as cumulative incidence, is defined as the probability that a particular event, such as occurrence of a particular disease, has occurred in a specified period: Incidence = \frac For example, if a population contains 1,000 persons and 28 develop a condition from the time the disease first occurred until two years later, the cumulative incidence is 28 cases per 1,000 persons, i.e. 2.8%. Incidence rate The incidence rate can be calculated by dividing the number of subjects developing a disease by the total time at risk from all patie ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rare Disease
A rare disease is any disease that affects a small percentage of the population. In some parts of the world, the term orphan disease describes a rare disease whose rarity results in little or no funding or research for treatments, without financial incentives from governments or other agencies. Orphan drugs are medications targeting orphan diseases. Most rare diseases are genetic in origin and thus are present throughout the person's entire life, even if symptoms do not immediately appear. Many rare diseases appear early in life, and about 30% of children with rare diseases will die before reaching their fifth birthdays. Fields condition is considered the rarest known disease, affecting three known individuals, two of whom are identical twins. With four diagnosed patients in 27 years, ribose-5-phosphate isomerase deficiency is considered the second rarest. While no single number has been agreed upon for which a disease is considered rare, several efforts have been undertaken to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country. Designation of a drug as an orphan drug has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug medical research, research and development. Examples of this can be that in the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to en ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Wearable Computer
A wearable computer, also known as a body-borne computer, is a computing device worn on the body. The definition of 'wearable computer' may be narrow or broad, extending to smartphones or even ordinary wristwatches. Wearables may be for general use, in which case they are just a particularly small example of mobile computing. Alternatively, they may be for specialized purposes such as fitness trackers. They may incorporate special sensors such as accelerometers, heart rate monitors, or on the more advanced side, Electrocardiography, electrocardiogram (ECG) and Oxygen saturation (medicine), blood oxygen saturation (SpO2) monitors. Under the definition of wearable computers, we also include novel user interfaces such as Google Glass, an optical head-mounted display controlled by gestures. It may be that specialized wearables will evolve into general all-in-one devices, as happened with the convergence of Personal digital assistant, PDAs and mobile phones into smartphones. Wearables ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Humanitarian Use Device
A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. Generally, these are known as orphan devices. The FDA calls such a device approved in this manner a "Humanitarian Use Device" (HUD). Requirements To qualify, the device must be intended to benefit patients with a rare disease or condition (i.e. fewer than 8,000 people in the US annually). The applicant must also show that there is no other way that the device could be brought to market, and that there is no comparable device already available. See also *Federal Food, Drug, and Cosmetic Act *Premarket approval The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of ... Notes Food and Drug Ad ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
In Vitro Diagnostics
A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. Medical tests such as, physical and visual exams, diagnostic imaging, genetic testing, chemical and cellular analysis, relating to clinical chemistry and molecular diagnostics, are typically performed in a medical setting. Types of tests By purpose Medical tests can be classified by their purposes, including diagnosis, screening or monitoring. Diagnostic A diagnostic test is a procedure performed to confirm or determine the presence of disease in an individual suspected of having a disease, usually following the report of symptoms, or based on other medical test results. This includes posthumous diagnosis. Examples of such tests are: * Using nuclear medicine to examine a patient suspected of having a lymphoma. * Measuring the blood sugar in a person suspected of having diabetes mellitus after periods of in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals And Medical Devices Agency
The (PMDA) is a Japanese corporation, an Independent Administrative Institution, responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. It is similar in function, in many respects, to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines. The PMDA has been eCTD-compliant at least since July 2017. Tasks Among other things, the agency is tasked with the following: * Drug and medical device testing: ** Scientific review of market authorization applications based on Japanese pharmaceutical law ** Advice in clinical trials or in the preparation of dossiers for the registration procedure (New Drug Applications (NDA)) ** Inspection and conformity assessment of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pract ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Effectiveness
Effectiveness or effectivity is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression. Etymology The origin of the word ''effective'' stems from the Latin word , which means "creative, productive, or effective". It surfaced in Middle English between 1300 and 1400 AD. Usage Science and technology Mathematics and logic In mathematics and logic, ''effective'' is used to describe metalogical methods that fit the criteria of an effective procedure. In group theory, a group element acts ''effectively'' (or ''faithfully'') on a point, if that point is not fixed by the action. Physics In physics, an effective theory is, similar to a phenomenological theory, a framework intended to explain certain (observed) effects without the claim that the theory correctly models the underlying (unobserved) processes. In heat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Orphan Drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation (if there is any) of the country. Designation of a drug as an orphan drug has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug medical research, research and development. Examples of this can be that in the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to en ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
